Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various Malignancies

Nader Hirmas; Rainer Hamacher; Miriam Sraieb; Lukas Kessler; Kim M. Pabst; Francesco Barbato; Helena Lanzafame; Stefan Kasper; Michael Nader; Claudia Kesch; Bastian von Tresckow; Hubertus Hautzel; Clemens Aigner; Martin Glas; Martin Stuschke; Sherko Kümmel; Philipp Harter; Celine Lugnier; Waldemar Uhl; Boris Hadaschik; Viktor Grünwald; Jens T. Siveke; Ken Herrmann; Wolfgang P. Fendler

doi:10.2967/jnumed.123.266652

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TABLE 1.

Patient Characteristics (n = 115)

Variable	Data
Sex
Male	71 (62%)
Female	44 (38%)
Median age at ⁶⁸Ga-FAPI scan (y)	63 (17)
Tumor entities
Prostate	22 (19%)
Head and neck	18 (16%)
Breast	16 (14%)
Colorectal	15 (13%)
Bladder	12 (10%)
Myeloma	12 (10%)
Kidney	10 (9%)
Lymphoma	10 (9%)
Regional detection with ⁶⁸Ga-FAPI scan^*
No evidence of disease	15 (13%)
Primary or local disease detected	42 (37%)
Lymph node metastases detected	28 (24%)
Visceral metastases detected	38 (33%)
Bone metastases detected	24 (21%)
Scanning purposes
Staging at initial diagnosis	34 (30%)
Restaging after therapy	81 (70%)
Prior therapy received^*
None	35 (30%)
Surgery	65 (57%)
Chemotherapy	53 (46%)
Radiation therapy	31 (27%)
Immune therapy	20 (17%)
Hormone therapy	16 (14%)
Radionuclide therapy	3 (3%)
Median uptake time (min)
⁶⁸Ga-FAPI	15 (25)
¹⁸F-FDG	65 (21)
Median time between ⁶⁸Ga-FAPI and ¹⁸F-FDG (d)	0 (2)

↵* Different combinations are possible; hence, values do not add to 100%.
Qualitative data are number and percentage; continuous data are median and interquartile range.

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TABLE 2.

Comparison of Diagnostic Efficacy Between ⁶⁸Ga-FAPI and ¹⁸F-FDG PET (Per-Patient and Per-Region Analysis) for Tumors in Which ⁶⁸Ga-FAPI Outperformed ¹⁸F-FDG PET

Tumor entity	n	Stratification	PET-positive/ total	Sensitivity	Specificity	PPV	NPV	Accuracy
⁶⁸Ga-FAPI PET
Colorectal	14	Per-patient	11/14	90.9 (58.7–99.8)	66.7 (9.4–99.2)	90.9 (66.6–98)	66.7 (20.8–93.9)	85.7 (57.2–98.2)
		Per-region	17/45	94.1 (71.3–99.9)	96.4 (81.7–99.9)	94.1 (69.9–99.1)	96.4 (80.1–99.5)	95.6 (84.9–99.5)
Prostate	22	Per-patient	22/22	100 (84.6–100)	—	100	—	100
		Per-region	33/55	94.3 (80.8–99.3)	100 (83.2–100)	100	90.9 (72.3–97.5)	96.4 (87.5–99.6)
¹⁸F-FDG PET
Colorectal	14	Per-patient	10/14	81.8 (48.2–97.7)	66.7 (9.43–99.2)	90 (63.9–97.9)	50 (18.4–81.6)	78.6 (49.2–95.3)
		Per-region	17/45	88.2 (63.6–98.5)	92.9 (76.5–99.1)	88.2 (66.1–96.7)	92.9 (77.9–98)	91.1 (78.8–97.5)
Prostate	22	Per-patient	20/22	90.9 (70.84–98.9)	—	100	—	90.9
		Per-region	31/55	88.6 (73.3–96.8)	100 (83.2–100)	100	83.3 (66.53–92.63)	92.7 (82.41–97.98)

Data in parentheses are 95% CI.

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TABLE 3.

Comparison of Diagnostic Efficacy Between ⁶⁸Ga-FAPI and ¹⁸F-FDG PET (Per-Patient and Per-Region Analysis) for Tumors in Which ⁶⁸Ga-FAPI Was Comparable to ¹⁸F-FDG PET

Tumor entity	n	Stratification	PET-positive/total	Sensitivity	Specificity	PPV	NPV	Accuracy
⁶⁸Ga-FAPI PET
Breast	16	Per-patient	15/16	100 (78.2–100)	100 (2.5–100)	100	100	100 (79.4–100)
		Per-region	28/47	96.6 (82.2–100)	100 (81.5–100)	100	94.7 (72.4–99.2)	97.9 (88.7–100)
Head and neck	10	Per-patient	10/10	100 (66.4–100)	0 (0–97.5)	90 (90)	—	90.0 (55.5–99.8)
		Per-region	17/31	93.8 (69.8–99.8)	86.7 (59.5–98.3)	88.2 (67.2–96.5)	92.9 (65.9–98.9)	90.3 (74.3–98)
¹⁸F-FDG PET
Breast	16	Per-patient	15/16	100 (78.2–100)	100 (2.5–100)	100	100	100 (79.4–100)
		Per-region	28/47	100 (88.1–100)	100 (81.5–100)	100	100	100 (92.5–100)
Head and neck	10	Per-patient	10/10	100 (66.4–100)	—	90 (90)	—	90.0 (55.5–99.8)
		Per-region	18/31	100 (79.4–100)	86.7 (59.5–98.3)	88.9 (68.8–96.7)	100	93.6 (78.6–99.2)

Data in parentheses are 95% CI.

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TABLE 4.

Comparison of Diagnostic Efficacy Between ⁶⁸Ga-FAPI and ¹⁸F-FDG PET (Per-Patient and Per-Region Analysis) for Tumors in Which ⁶⁸Ga-FAPI Underperformed in Comparison to ¹⁸F-FDG PET

Tumor entity	n	Stratification	PET-positive/total	Sensitivity	Specificity	PPV	NPV	Accuracy
⁶⁸Ga-FAPI PET
Bladder	12	Per-patient	8/12	72.7 (39–94)	100 (2.5–100)	100	25 (11.3–46.7)	75 (42.8–94.5)
		Per-region	12/37	78.6 (49.2–95.3)	95.7 (78.1–99.9)	91.7 (61.34–98.7)	88 (72.8–95.3)	89.2 (74.6–97)
Kidney	10	Per-patient	8/10	87.5 (47.4–99.7)	50 (1.26–98.7)	87.5 (63.1–96.6)	50 (9.13–90.9)	80 (44.4–97.5)
		Per-region	15/31	92.9 (66.1–99.8)	88.2 (63.6–98.5)	86.7 (63.7–96)	93.8 (69.2–99)	90.3 (74.3–98)
Lymphoma	9	Per-patient	7/9	87.5 (47.4–99.7)	100 (2.5–100)	100	50 (13.8–86.2)	88.9 (51.8–99.7)
		Per-region	11/30	78.6 (49.2–95.3)	100 (79.4–100)	100	84.2 (66.2–93.6)	90 (73.5–97.9)
Myeloma	10	Per-patient	6/10	75 (34.9–96.8)	100 (15.8–100)	100	50 (23.1–76.9)	80 (44.4–97.5)
		Per-region	6/10	75 (34.9–96.8)	100 (15.8–100)	100	50 (23.1–76.9)	80 (44.4–97.5)
¹⁸F-FDG PET
Bladder	12	Per-patient	11/12	100 (71.5–100)	100 (2.5–100)	100	100	100 (73.5–100)
		Per-region	13/36	92.3 (64–99.8)	95.7 (78.1–99.9)	92.31 (63.7–98.8)	95.7 (77–99.3)	94.4 (81.3–99.3)
Kidney	10	Per-patient	7/10	87.5 (47.4–99.7)	100 (15.8–100)	100	66.7 (24.2–92.6)	90 (55.5–99.8)
		Per-region	14/31	92.9 (66.1–99.8)	94.1 (71.3–99.9)	92.9 (65.9–98.9)	94.12 (70.7–99.1)	93.55 (78.6–99.2)
Lymphoma	9	Per-patient	8/9	100 (63.1–100)	100 (2.5–100)	100	100	100 (66.4–100)
		Per-region	15/30	100 (76.8–100)	93.8 (69.8–99.8)	93.33 (67.7–98.9)	100	96.7 (82.8–99.9)
Myeloma	10	Per-patient	7/10	87.5 (47.4–99.7)	100 (15.8–100)	100	66.7 (24.2–92.6)	90 (55.5–99.8)
		Per-region	7/10	87.5 (47.4–99.7)	100 (15.8–100)	100	66.7 (24.2–92.6)	90 (55.5–99.8)